Intravenous catheter insertion device and method of use

ABSTRACT

A catheter insertion device with a housing and an interior space. An access needle and a guide wire supported by and moveable relative to the access needle. A restraining element attached to a handle to limit the motion of the guide wire relative to the access needle. A catheter insertion device with a housing and an interior space. An access needle and a guide wire channel attached to the access needle. A guide wire supported by the guide wire channel. A handle attached to the guide wire to move the guide wire relative to the guide wire support channel. A method of introducing a catheter into a vessel by inserting a guide wire substantially contained within a housing into a vessel. Next, advance a catheter over the guide wire and into the vessel. Next, withdraw the guide wire out of the vessel and completely into the housing.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. 365 (c) and is acontinuation in part application of U.S. patent application Ser. No.11/577,491 filed Apr. 18, 2007 titled “Intravenous Catheter InsertionDevice and Method of Use” and claims the benefit under 35 U.S.C. 365 (c)and is a continuation in part application of PCT/US2006/026671 filedJul. 6, 2006, titled “Intravenous Catheter Insertion Device and Methodof Use” which claims the benefit of U.S. Provisional Patent ApplicationSer. No. 60/697,333, filed on Jul. 6, 2005. Each of these patentapplications and all patents and patent applications referred to in thisapplication are each incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to devices and methods for insertion andplacement of an intravenous catheter into a vein or artery of a patient.The devices and methods of the invention facilitate safe placement ofthe catheter into the patient's vein or artery, which is of particularimportance in the case of small, tortuous, collapsed, fragile, and/ordifficult to locate vessels. The devices and methods also provideprotection against accidental punctures and/or contamination by theneedle after placement of the intravenous catheter.

BACKGROUND OF THE INVENTION

The following patents describe prior intravenous catheter insertiondevices and/or safety devices for syringes and needles.

-   Haining—EP00515710A1 Intravenous catheter and insertion device-   Haining—EP00515710B1 Intravenous catheter and insertion device-   Haining—US05019049 Intravenous catheter and insertion device-   Haining—US05176650 Intravenous catheter and insertion device-   Chang—EP00567321A2 Intravenous catheter with needle guard-   Mahurkar—EP00652020B1 Retractable hypodermic needle assembly-   Mahurkar—EP00910988A1 Blood sample collection assembly-   Mahurkar—US05891105 Hypodermic needle assembly-   DeWitt—US03572334 Intravenous catheter placement unit-   van Heugten—EP00750916A2 Protective needle cover containment-   Botich—EP00942761B1 Medical device with retractable needle-   Botich—EP01075850B1 Apparatus for intravenous catheter insertion-   Botich et al—US05800395 Medical device with retractable needle-   Botich et al—US06436070 Catheter insertion device with retractable    needle-   Botich et al—US23060760A1 Catheter insertion device with retractable    needle-   Botich—et al WO00012160A1 Fluid infusion device with retractable    needle-   Botich—WO09632981A1 Safety stylet for intravenous catheter insertion-   Botich—WO09824494A1 Medical device with retractable needle-   Shue—EP01457229A1 Intravenous catheter inserting device-   Shue—US24106903A1 Intravenous catheter inserting device-   Harautuneian—US03592192 Intravenous catheter apparatus with catheter    telescoped on outside of puncturing cannula-   Harautuneian—US03610240 Intravenous catheter apparatus with catheter    telescoped inside puncturing cannula-   Poncy et al—US04037600 Catheter placement system-   Hession—US04292970 Apparatus for intravenous catheter starter-   McDonald—US04834718 Safety needle apparatus-   McDonald—US04944725 Safety needle apparatus-   Vining et al—US04909793 Intravenous catheter apparatus with    retractable stylet-   Carrell et al—US04944728 Intravenous catheter placement device-   Kaufman—US04966589 Intravenous catheter placement device-   Shields—US05007901 Intravenous catheter insertion device-   Haughton et al—US05562629 Catheter placement system utilizing a    handle, a sharp, and a releasable retainer mechanism providing    retraction of the sharp upon disengagement of the catheter from the    handle-   Flumene et al—US05562634 Intravenous catheter with automatically    retracting needle-guide-   Isaacson—US05573510 Safety intravenous catheter assembly with    automatically retractable needle-   Isaacson—US06056726 Self-contained safety intravenous catheter    insertion device-   Isaacson—WO09523003A1 Self-contained safety intravenous catheter    insertion device-   Huang—US05891098 Safety intravenous catheter-   Bhitiyakul—US05941854 Intravenous catheter-   Dysarz—US05997507 Biased spring hard needle retractable N catheter-   Dysarz—US06193690 Inclined plane latching device for an N catheter-   Greene et al—US06221047 Safety intravenous catheter assembly and    method for use with a needle-   Greene et al—US06689102 Safety intravenous catheter assembly-   Greene et al—US06695814 Safety intravenous catheter assembly and    method for use with a needle-   Greene et al—US21014786A1 Safety intravenous catheter assembly and    method for use with a needle-   Greene et al—US22165497A1 Safety intravenous catheter assembly-   Greene et al—WO00006226A1 Safety intravenous catheter assembly and    method for use with a needle-   Chang—US06322537 Safety intravenous catheter-   Pressly, Sr. et al—US06620136 Retractable I-V catheter placement    device-   Pressly, Sr. et al—WO00047256A1 Retractable I-V catheter placement    device-   Hoffman et al—US06730062 Safety catheter with non-removable    retractable needle-   Hoffman et al—US23073956A1 Safety catheter with non-removable    retractable needle-   Brustowicz—US24267204A1 On-demand needle retaining and locking    mechanism for use in intravenous catheter assemblies-   Garcia Andreo—WO03043686A1 Flow regulating/autovalve intravenous    catheter-   Sircom—WO09222344A1 Needle guard for intravenous catheter placement-   Ogle—WO09519193A1 Retractable venipuncture catheter needle and    receptacle-   Rohrbough et al—WO09705912A2 Retractable venipuncture catheter    needle and receptacle-   Hwang—WO09721458A1 Intravenous catheter with flexible extender and    protector against needle tip

SUMMARY OF THE INVENTION

In one embodiment of the present invention, there is provided a catheterinsertion device having a housing having an interior space; an accessneedle that is slideable with respect to the interior space; a guidewire supported by and moveable relative to the access needle; a handleattached to the guide wire that is moveable relative to the housing tomove the guide wire relative to the interior space; and a restrainingelement attached to the handle to limit the motion of the guide wirerelative to the access needle.

In one aspect, the restraining element attached to the handle limits theproximal motion of the guide wire relative to the access needle. Inanother aspect, wherein the access needle comprises a bleed backindicator within the portion of the access needle extending beyond thehousing. In another aspect, the access needle comprises a bleed backindicator visible in the distal end of a catheter when the access needleis positioned within a catheter. In a further aspect, the bleed backindicator comprises an opening in the sidewall of the distal end of theaccess needle.

In another embodiment, the catheter insertion device also includes abiasing element and a release button adapted and configured toautomatically withdraw one or both of the guide wire and the accessneedle. In a further aspect, the biasing element and the release buttonare adapted and configured to simultaneously withdraw the guide wire andthe access needle into the interior space. In another aspect, biasingelement and the release button are adapted and configured tosequentially withdraw the guide wire and the access needle. In oneembodiment, the catheter insertion device also includes a restrainingelement within the interior space that limits distal movement of theaccess needle or guide wire within the interior space. In onealternative, the restraining element limits distal movement of theaccess needle or guide wire after the access needle or guide wire havebeen withdrawn into the interior space after use to insert a catheter.In another alternative, the restraining element limits distal movementof the access needle or guide wire such that the access needle and guidewire remain completely withdrawn into the interior space.

In one embodiment of the catheter insertion device, the interior spaceis sized and configured to contain all of the guide wire and the accessneedle after insertion of a catheter. In another aspect, the guide wirehas a first portion with a first diameter, a reducing section and asecond portion with a second diameter that is less than the firstdiameter. In still a further aspect, the first diameter and the seconddiameter are less than the interior diameter of the access needle. Instill another aspect, the distal end of the second portion comprises oneor more of a full radius distal tip, a spherical ball of the samematerial as the guide wire, a spherical ball of a different materialthan the guide wire or a distal end having a diameter about the same asthe first diameter. In one alternative, the guide wire comprises abraided structure. In yet another alternative, the catheter insertiondevice includes a guide channel within the housing to confine themovement of the handle and a holding channel adjacent to the guidechannel wherein the holding channel is adapted to prevent movement ofthe handle once the handle is in the holding channel. In one aspect, therestraining element prevents proximal guide wire movement and theholding channel prevents distal guide wire movement. In another aspectthere is a pulley secured within the interior space configured tofacilitate movement of the guide wire into the interior space.

In another embodiment, there is provided a catheter insertion devicehaving a housing having an interior space; an access needle having adistal end, a proximal end and an interior wall defining a lumen thatextends from the distal end to the proximal end; an access needle thatis slideable relative to the interior space; an opening in the sidewallof the access needle in communication with the access needle lumen; anda guide wire supported by the access needle. In another aspect, thecatheter insertion device also includes a restraining element attachedto the guide wire and configured to prevent the guide wire from movinginto the opening. In one aspect, there is also a restraining elementattached to the guide wire wherein when the guide wire is positionedwithin the access needle distal to the opening the restraining elementlimits proximal movement of the guide wire towards the opening. Inanother alternative, the access needle lumen has a cross section shapethat maintains the orientation of the guide wire relative to the accessneedle lumen. In one aspect, the access needle lumen has a non-circularcross section shape. In another aspect, the access needle lumen has anelliptical cross section shape. In another aspect, there is also afeature formed within the access needle sidewall to maintain theorientation of the guide wire relative to the access needle lumen. Inone alternative, the feature is a groove. In one aspect, the opening inthe sidewall of the access needle is positioned proximal to the distalend of the access needle.

In another alternative, the opening in the sidewall of the access needleis positioned distal to the distal end of the housing. In anotheralternative, the access needle constrains the guide wire into anon-coiled configuration within the access needle. In anotheralternative, the guide wire is coiled within the access needle. In oneaspect, the guide wire is coiled to form at least one half of a rotationwithin the access needle lumen. In another aspect, the guide wire iscoiled to form one or more rotations within the access needle lumen. Instill another aspect, the guide wire is within the access needle. Inanother aspect, the guide wire is alongside the access needle. In oneembodiment, there is also a guide wire channel supported by the accessneedle.

In another embodiment of the catheter insertion device of the invention,there is provided a housing having an interior space and a longitudinalaxis; a feature on the distal end of the housing that when coupled to acatheter offsets the housing longitudinal axis from the longitudinalaxis of the catheter; and an access needle passing through the featureand attached to a needle carrier wherein the needle carrier is slideablewith respect to the interior space and the access needle is slideablerelative to the feature. In one alternative, when the feature on thedistal end of the housing is coupled to the catheter the housinglongitudinal axis is offset from the longitudinal axis of the catheterto form an angle of less than 180 degrees. In one alternative, when thefeature on the distal end of the housing is coupled to the catheter thehousing longitudinal axis is offset from the longitudinal axis of thecatheter to form an angle of less than 60 degrees. In anotheralternative, when the feature on the distal end of the housing iscoupled to the catheter the housing longitudinal axis is offset from thelongitudinal axis of the catheter to form an angle of less than 45degrees. In another alternative, there is also a guide wire supported byand moveable relative to the access needle. In another alternative,there is also a handle attached to the guide wire that is moveablerelative to the housing to move the guide wire relative to the interiorspace. In another alternative, there is also a restraining elementattached to the handle to limit the motion of the guide wire relative tothe access needle. In one aspect, when the access needle and the guidewire are withdrawn into the interior space the guide wire and the accessneedle are withdrawn substantially parallel to the longitudinal axis ofthe housing. In another aspect, the guide wire is disposed within theaccess needle. In another aspect, the guide wire is alongside the accessneedle.

In another embodiment of the catheter insertion device of the invention,there is a housing having an interior space; an access needle that isslideable with respect to the interior space; a guide wire supported byand moveable relative to the access needle; and a handle attached to theguide wire wherein the movement of the handle is limited so that atleast a portion of the guide wire always remains in the interior space.In another alternative, there is also a biasing element adapted andconfigured to move the needle carrier proximally within the interiorspace when released. In one aspect, the biasing element is adapted andconfigured to move the guide wire proximally within the interior spacewhen released. In one aspect, the biasing element is adapted andconfigured that, when released, moves the needle so that the needle iscompletely within the interior space. In another aspect, the biasingelement is adapted and configured to move the guide wire so that theentire length of the guide wire is completely within the interior space.In another alternative, there is also a restraining element within theinterior space that limits distal movement of the access needle or guidewire within the interior space once the access needle or guide wire hasmoved proximal to the restraining device. In one aspect, one end of theguide wire is secured to the housing. In one aspect, one end of theguide wire is constrained within the interior space when the guide wireis extended beyond the distal end of the access needle. In one aspect,the guide wire is disposed within the access needle. In another aspect,the guide wire is disposed alongside the access needle.

In another embodiment of the catheter insertion device of the invention,there is provided a housing having an interior space; an access needlethat is slideable with respect to the interior space; a guide wirechannel attached to the access needle; a guide wire supported by andmoveable relative to the guide wire channel; and a handle attached tothe guide wire wherein the movement of the handle moves the guide wirerelative to the support channel. In one aspect, the movement of thehandle is limited so that at least a portion of the guide wire alwaysremains in the interior space. In another aspect, there is also provideda biasing element and a release button adapted and configured toautomatically withdraw one or both of the guide wire and the accessneedle. In another aspect, there is also provided a restraining elementwithin the interior space that limits distal movement of the accessneedle or guide wire within the interior space. In one aspect, thedistal end of the guide wire channel is adjacent the distal end of theaccess needle. In another aspect, the guide wire channel is on the topof the access needle. In another aspect, the guide wire channel is onthe bottom of the access needle. In another aspect, the guide wirepasses out the distal end of the guide wire channel without passingthrough the access needle lumen. In still another aspect, the guide wirepasses out the distal end of the guide wire channel and through aportion of the access needle lumen. In another aspect, the guide wirechannel is attached to the access needle within the access needle lumen.

In other embodiments of the invention, there are provided severalmethods of introducing a catheter into a vessel including inserting aguide wire substantially contained within a housing into a vessel;advancing a catheter over the guide wire and into the vessel; andwithdrawing the guide wire out of the vessel and completely into thehousing. In one alternative, the step of advancing the guide wire alonga needle inserted into the vessel is performed before performing theinserting step. In one alternative, the step of advancing the guide wirealong a needle inserted into the vessel is performed before performingthe inserting step. In another alternative, the step of coiling theguide wire within the vessel is performed after the inserting step.

In one aspect, the withdrawing step is accomplished manually. In anotheraspect, the withdrawing step is accomplished automatically. In anotheralternative, the withdrawing step is accomplished by releasing a biasingmember to withdraw the guide wire completely into the housing. Inanother alternative, releasing a biasing member also withdraws a needlesupporting the guide wire completely into the housing. In anotheralternative, the withdrawing step is initiated by pushing a button. Inanother alternative, inserting a needle attached to the housing into thevessel is performed before the step of inserting a guide wire step. Inanother alternative, the method also includes using a flashbackindicator near the distal tip of the needle to determine that the needlehas entered the vessel after the inserting a needle step. In anotheralternative, the method also includes moving a handle attached to theguide wire proximally before the inserting step.

Although the invention is described in relation to insertion of anintravenous catheter, the apparatus and methods described herein couldreadily be adapted for insertion of any catheter or similar device intoa vein, artery or other internal body structure.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 shows an exploded view of an intravenous catheter insertiondevice according to the present invention.

FIG. 2 shows an assembly drawing of the intravenous catheter insertiondevice in an undeployed state, ready for use.

FIG. 3 shows a phantom view of the intravenous catheter insertion devicewith the safety guide wire advanced.

FIGS. 4A and 4B are detail drawings of a safety guide wire for use withthe intravenous catheter insertion device.

FIGS. 5A, 5B and 5C are detail drawings of another safety guide wire foruse with the intravenous catheter insertion device.

FIG. 6 shows another embodiment of an intravenous catheter insertiondevice according to the present invention.

FIGS. 7-9 illustrate a method of intravenous catheter insertionaccording to the present invention.

FIGS. 10A and 10B illustrate cross section views of one embodiment of acatheter insertion device.

FIG. 10C is a section view of catheter hub with an angled base and FIG.10D illustrates a section view of a conventional catheter.

FIGS. 10E and 10F are top down views of an access needle having onebleed back indicator (FIG. 10E) or two bleed back indicators (FIG. 10F).

FIG. 10G is a top down view of a catheter insertion device inserted intoa catheter;

FIGS. 11A-14B illustrate a catheter insertion device in use to insert acatheter into a vessel and automatically withdrawn the access needle andguide wire into a housing;

FIG. 15 is a section view of an alternative catheter insertion devicewith a restraint to prevent unintended distal movement within thehousing interior;

FIGS. 16A and 16B illustrate perspective and end views, respectively, ofan access needle adapted to maintain the orientation of a guide wire;

FIGS. 17A and 17B illustrate perspective and end views, respectively, ofan access needle adapted to maintain the orientation of a guide wire;

FIGS. 18A-18H illustrate section and perspective views of the use of acatheter insertion device having a guide channel and restrainingfeatures;

FIGS. 19A and 19B are side and section views respectively of thecatheter of FIG. 10C;

FIG. 20 is a side view of a catheter insertion device with a housingoffset angle;

FIG. 21 is a section view of a catheter insertion device with an offsetlongitudinal axis;

FIGS. 22, 23 and 24 illustrate guide wire alternatives;

FIGS. 25A and 25B illustrate side and end views, respectively, of acoiled portion of a guide wire;

FIG. 26A illustrates a section view of a catheter insertion device withthe guide wire extended;

FIG. 26B illustrates section view of catheter insertion device of FIG.26B where a pulley has been used to withdraw the guide wire completelyinto the housing;

FIGS. 27A-27E illustrate section views of the access needle of acatheter insertion device with an attached guide wire channel.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows an exploded view of one embodiment of an intravenouscatheter insertion device 20 according to the present invention. FIG. 2shows an assembly drawing of the intravenous catheter insertion device20 in an undeployed state, ready for use. FIG. 3 shows a phantom view ofthe intravenous catheter insertion device 20 with the safety guide wireadvanced.

The intravenous catheter insertion device 20 includes an outer housing1. In the example shown, the outer housing 1 is in the form of anelongated hollow cylinder. Other shapes, including an ergonomic handleshape, are possible. The outer housing 1 may be formed from any materialsuited for use in medical applications. In one embodiment, the outerhousing 1 is preferably molded from a rigid, transparent medical gradeplastic. Alternatively, the outer housing 1 may be machined from anextruded plastic tube.

There is an elongated slot 14 in the outer housing 1 approximatelyparallel with the axis of the outer housing 1. The slot 14 is sized toaccommodate the dowel pin 10 or provide a connection point to the slider4 to move the slider along the interior of the outer housing 1. Thedistal end of the slot 14 widens into a triangular cutout 15, as seen inFIGS. 2 and 3. Other shapes of the cut out 15 are possible.

A front plug 2 is sized to fit onto the distal end of the outer housing1. The front plug 2 is preferably molded, or alternatively machined,from a rigid, transparent medical grade plastic. The front plug 2 isglued, pinned, welded or otherwise fastened to the distal end of theouter housing 1. The distal end of the front plug 2 includes a luer slipfitting 16 or the like. There is a shoulder or flange 17 to mate withthe distal end of the outer housing 1. The proximal end of the frontplug 2 has an interlocking member 18 that interlocks with a matinginterlocking member 19 on the needle carrier 6. In the example shown,the interlocking member 18 is a tab that interlocks with a correspondingspiral pawl or quarter-turn thread interlocking member 19 on the needlecarrier 6. Other geometries for the interlocking members 18, 19 arepossible.

In the exemplary embodiment of FIGS. 1-3, the geometry of the slot 14and the triangular cutout 15 are chosen to operate cooperatively withthe rotating interlocking members 18, 19. The slot 14 allows theactuator handle 9 to move in a longitudinal direction with respect tothe outer housing 1 to advance the safety guide wire 11 distally, whileat the same time restricting lateral motion to avoid prematurewithdrawal of the access needle 8 and the safety guide wire 11. Thewidening of the slot 14 at the distal end into a triangular cutout 15allows the actuator handle 9 to be selectively rotated laterally todisengage the rotating interlocking members 18, 19 and release thebiasing member 12 to withdrawal of the access needle 8 and the safetyguide wire 11 after the safety guide wire 11 has been fully advanced. Ifa different geometry or different release mechanism is used in place ofthe rotating interlocking members 18, 19, the geometry of the slot 14and the triangular cutout 15 may have to be modified to accommodate therelease mechanism.

The needle carrier 6 is shaped and sized to fit inside the outer housing1. In the embodiment shown in FIGS. 1-3, the needle carrier 6 has acylindrical shape that is sized to have a sliding fit within thecylindrical outer housing 1. Other shapes are possible and generally theneedle carrier 6 will be shaped to be compatible with the interiorgeometry of the outer housing 1. The needle carrier 6 is preferablymolded, or alternatively machined, from any material suited for use in amedical environment. In one embodiment, the needle carrier 6 is formedfrom a rigid, transparent medical grade plastic. A tubular access needle8 with a sharpened beveled distal end is attached to a needle carriernose 5, which is in turn attached to the needle carrier 6. The accessneedle 8 is preferably made from stainless steel hypodermic tubing. Asmall cavity or blood flashback chamber that communicates with the lumenof the access needle 8 is positioned within the needle carrier 6,between the needle carrier nose 5 and the needle carrier 6. As mentionedabove, the distal end of the needle carrier 6 has an interlocking member19 that is configured to interlock with a mating interlocking member 18on the proximal end of the front plug 2. In one exemplary embodiment,the interlocking members 18, 19 are adapted to lock and unlock byrotation of the needle carrier 6 with respect to the front plug 2. Theinterlocking members 18, 19 may also lock and unlock using abayonet-type fitting. In the example shown, the interlocking member is aspiral pawl interlocking member 19 that interlocks with a correspondingtab interlocking member 18 on the front plug 2. In one embodiment, theinterlocking members lock and/or unlock using less than one revolutionof the needle carrier 6. In another embodiment, the interlocking memberslock and/or unlock using less than one half a revolution of the needlecarrier 6. In still another alternative embodiment, the interlockingmembers lock and/or unlock using less than one quarter revolution of theneedle carrier 6. Other geometries for the interlocking members arepossible.

A biasing member 12 is configured to fit between the needle carrier 6and the front plug 2 to urge them apart. The force of the biasing member12 is resisted by the interlocking members 18, 19 when the needlecarrier 6 and the front plug 2 are locked together. In one embodiment,the biasing member 12 is a spring. Note that in FIG. 1 the biasingmember or compression spring 12 is shown in a compressed condition as itwould be in the assembled intravenous catheter insertion device 20 in anundeployed condition.

In an alternate embodiment, the interlocking members 18, 19 may bereplaced by two members that are bonded together with a breakable bondor a single member with a breakable link. The member or members would beconfigured to constrain the biasing member 12 until it is desired towithdraw the access needle 8 and safety guide wire 11, at which time;the actuator would break the bond or link to release the biasing member12. This configuration would make the device 20 more resistant toremanufacturing or reuse.

A tubular intravenous catheter 13, such as an ANGIOCATH, fits coaxiallyaround the access needle 8. Preferably, the intravenous catheter 13 hasa close fit with the access needle 8 and a tapered distal end tominimize any step between the access needle 8 and the intravenouscatheter 13 as they are inserted through the wall of a vein. There is aluer fitting 27 or the like on the proximal end of the intravenouscatheter 13 that fits onto the luer slip fitting 16 on the distal end ofthe front plug 2 with a slight interference fit to hold the intravenouscatheter 13 in place. Alternative configurations of the device may use aluer lock or other locking mechanism to attach the intravenous catheter13 to the front plug 2.

A slider 4 is generally cylindrical in shape and sized for a sliding fitinside the cylindrical outer housing 1. Other shapes for the slider 4are possible depending on the interior geometry of the outer housing 1.The slider 4 is preferably molded, or alternatively machined, from anysuitable medical grade material. For example, the slider may be formedfrom a rigid medical grade plastic. A handle 9 or actuating memberattaches to the slider 4 with a dowel pin 10 or other attachment memberthat extends through the slot 14 in the outer housing 1. The slider 4fits into the outer housing 1 proximal to the needle carrier 6. A pin 25extends from the distal surface of the slider 4 and is configured toreversibly engage with a hole, step, boss or similar mating feature 26on the proximal end of the needle carrier 6. When pin 25 is coupled tothe mating feature 26 during the appropriate step of the intravenouscatheter insertion and placement procedure, rotation of the slider 4 istransferred to the needle carrier 6 to facilitate engagement and ordisengagement of the interlocking members 18, 19. Pin 25 and feature 26are merely illustrative. Pin 25 may be replaced with a female featurewhile a mating male feature may be placed on the proximal face of theneedle carrier 6. Additionally, the mating features 25, 26 are alignedrelative to the elongated slot and the sliding movement of the slider 4so that distal movement of the slider 4 will engage the mating features25, 26. Optionally, the device 20 may be configured so that theconnection between the slider 4 and needle carrier 6 happensirreversibly when the device 20 is actuated.

As best seen in FIG. 3, a safety guide wire 11 is attached, directly orindirectly, to the slider 4 so that it can be advanced and retractedwith the handle 9 attached to the slider 4. In a preferred embodiment,the safety guide wire 11 is constructed of super elastic Nickel-Titaniumalloy (Nitinol) wire. Because this type of wire is extremely flexible,it is advantageous to have the safety guide wire 11 enclosed along mostof its length to avoid bowing or buckling while advancing the safetyguide wire 11. For this reason, the example shown includes a supporttubing 7 that is attached to the proximal end of the needle carrier 6.The safety guide wire 11 extends through the internal lumen of a sheathtubing 3 and the proximal end of the safety guide wire 11 is attached atthe proximal end of the sheath tubing 3. The distal end of the sheathtubing 3 is in turn attached to the slider 4, indirectly attaching thesafety guide wire 11 to the slider 4. The support tubing 7 has a slidingfit inside the sheath tubing 3 so that the two parts telescope togetheras the slider 4 is advanced in the distal direction. The telescopingaction of the support tubing 7 and the sheath tubing 3 provides avariable-length support for the proximal portion of the safety guidewire 11 to prevent bowing or buckling of the safety guide wire 11 as itis advanced. The support tubing 7 and the sheath tubing 3 are preferablymade from stainless steel hypodermic tubing, however any suitablemedical grade plastic material may also be used. In other embodiments,such as those using a larger diameter or stiffer guide wire, thetelescoping support tubes may not be necessary and the proximal end ofthe safety guide wire 11 may be attached directly to the slider 4.

FIGS. 4A and 4B are detail drawings of a safety guide wire 11 for usewith the intravenous catheter insertion device 20. The safety guide wire11 is preferably constructed of super elastic Nickel-Titanium alloy wireapproximately 0.004-0.012 inches in diameter and most preferablyapproximately 0.008 inches in diameter. As shown in FIG. 4B, the distalend of the safety guide wire 11 is preformed into a tightly wound spiralwith an outer diameter smaller than the internal diameter of the targetvessel into which it will be inserted. The spiral tip acts as a safetybumper on the guide wire to avoid puncturing or damaging the inside oftarget vessels. The coiled guide wire tip is particularly useful inprotecting fragile or delicate veins. Due to the extreme flexibility ofthe Nickel-Titanium alloy wire, the spiral distal curve can straightenout when the safety guide wire 11 is withdrawn into the access needle 8and completely recover into the spiral configuration without plasticdeformation when the safety guide wire 11 is advanced out of the accessneedle 8. In the example shown, the distal end of the safety guide wire11 has a first, small diameter coil of approximately 0.167 inches indiameter for approximately 0.75 revolutions and a second, largerdiameter coil of approximately 0.175 inches in diameter forapproximately 1 revolution. The first and second coils are preferablyapproximately coplanar with one another and preferably approximatelycoplanar with the straight proximal portion of the guide wire 11 also.Other configurations of the safety guide wire 11 may include:multi-planar, single coil, full radius on the end, and/or a balled endwith diameter less than the diameter of the needle.

FIGS. 5A, 5B and 5C are detail drawings of another safety guide wire 11for use with the intravenous catheter insertion device 20. In thisembodiment, a distal portion of an approximately 0.008 inch diameterNickel-Titanium alloy wire has been tapered by grinding, stretching,etc., to a diameter of approximately 0.004 inches to make it moreflexible and to allow it to be formed into a smaller diameter spiral foruse in smaller diameter veins. The spiral curve of the guide wire tipwill preferably have an outer diameter smaller than the inner diameterof the target vessel. In the example shown, the spiral curve has afirst, small diameter coil of approximately 0.034 inches in diameter forapproximately 0.75 revolutions and a second, larger diameter coil ofapproximately 0.059 inches in diameter for approximately 1 revolution.The first and second coils are preferably approximately coplanar withone another and preferably approximately coplanar with the straightproximal portion of the guide wire 11 also.

Other sizes and geometries of safety guide wire 11 are also possible.

To assemble the intravenous catheter insertion device 20 shown in FIGS.1-3, the access needle 8 is bonded flush with the proximal face of theneedle carrier nose 5, which is in turn bonded into the needle carrier6. The support tubing 3 is placed into the distal hole in the needlecarrier 6, and bonded flush with the proximal face of the bloodflashback chamber. The formed safety guide wire 11 is advanced throughthe lumen of the access needle 8 and support tubing 7 until the coiledsection of the safety guide wire 11 meets the access needle 8 bevel. Thesheath tubing 3 is slid through the slider 4, and bonded when flush withthe distal face. The assembly of the sheath tubing 3 and slider 4 areadvanced over the safety guide wire 11. When the safety guide wire 11 isflush with the proximal end of the sheath tubing 3, the two are bonded.The spring 12 is compressed on the needle carrier nose 5, advanced intothe front plug 2 and the interlocking members 18, 19 of the front plug 2and needle carrier 6 are engaged. This assembly of components is placedinto the outer housing 1 and advanced until the front plug 2 is flushwith the outer housing 1, and then the front plug 2 is rotated forproper alignment. The front plug 2 is then bonded to the outer housing1. The dowel pin 10 and handle 9 are pressed together with the slider 4.The handle 9 is slid proximally to withdraw the safety guide wire 11into the access needle 8, thereby straightening out the spiral distalcurve. An intravenous catheter 13 is then mounted coaxially around theaccess needle 8. Optionally, the intravenous catheter 13 insertiondevice may be provided with a needle cover or other protectivepackaging. The assembled intravenous catheter insertion device 20,including the intravenous catheter 13, is then packaged, labeled andsterilized.

The preceding assembly description is provided to illustrate one exampleof a process for manufacturing an embodiment of the intravenous catheterinsertion device 20 and also so that the interrelationship of thevarious components will be understood. Modifications and variations ofthis description are expected depending upon specific selected assemblyor manufacturing techniques. For example, components that are bonded maybe redesigned to be formed from a single integrated piece and the like.The manufacturing process can be modified and adapted for assemblingother embodiments of the intravenous catheter insertion device 20.

FIG. 6 shows an interior view of another embodiment of an intravenouscatheter insertion device 20 according to the present invention. Thisembodiment is similar in many respects to the intravenous catheterinsertion device 20 of FIGS. 1-3. The intravenous catheter insertiondevice 20 includes an outer housing 1, front plug 2, which mayoptionally be molded integrally with the outer housing 1, a needle 8attached to a needle carrier 6, a safety guide wire 11, spring 12 andintravenous catheter 13. However, the functions of the handle 9 and theslider 4 have been replaced by a thumbwheel 21 that engages a pair offriction wheels 22, 23, which are in contact with the safety guide wire11. Likewise, the functions of the sheath tubing 3 and the supporttubing 7 have been replaced by a guide wire spool 24. These featuresallow the intravenous catheter insertion device 20 to be constructed ina more compact configuration. In use, the safety guide wire 11 isadvanced by turning the thumbwheel 21. A lateral movement of thethumbwheel 21 disengages the needle carrier 6 from the front plug 2,allowing the biasing member 12 to expand, thereby retracting the needle8 and the safety guide wire 11 into the outer housing 1. Alternatively,a separate button, lever or other actuation member can be provided toactuate the withdrawal of the needle 8 and the safety guide wire 11. Theguide wire spool 24 may optionally include a rotary spring or similarmechanism (not shown) to assist in the retraction of the safety guidewire 11 into the outer housing 1.

In one embodiment, the length of the guide wire 11 on the spool 24 ismore than twice the length of the housing 1. In another aspect, thelength of the guide wire on spool 24 is sufficient to provide guide wireaccess to a central vein. In one embodiment, the guide wire spoolcontains a guide wire having a length between 10 to 60 centimeters. Theguide wire spool 24 may also be configured to include a clutch, cam orother releasable engagement element to disengage the spool 24 duringadvancement of the guide wire 11 in order to reduce the force needed torotate thumbwheel 21 or wheels 22, 23. After advancement is completed,the releasable engagement element would then engage the retractionmechanism associated with the spool 24. Once guide wire withdrawal isdesired, the withdrawal mechanism is actuated. The use of the guide wirespool 24 allows for the use of a guide wire insertion length that ismuch longer than the length of the housing containing the guide wirespool

FIGS. 7-9 illustrate a method of inserting an intravenous catheter usingan intravenous catheter insertion device 20, such as those described inFIGS. 1-3 or FIG. 6. The intravenous catheter insertion device 20 is asingle-use, non-reusable device supplied to the physician or medicalpractitioner sterile in a ready-to-use, undeployed condition as shown inFIG. 2. In use, the physician uses the outer housing 1 as a handle tomanipulate the intravenous catheter insertion device 20. With the devicein the undeployed condition, the access needle 8 is used to puncture avein, as shown in FIG. 7. When venous blood is observed in the bloodflashback chamber, the distal tip of the access needle 8 is the lumen ofthe vein. The physician can then advance the handle 9 in the distaldirection to extend the safety guide wire 11 out of the access needle 8into the lumen of the vein. The distal portion of the safety guide wire11 assumes its spiral configuration to act as a safety bumper to preventaccidental puncture of the far wall of the vein or other damage to thevein. With the safety guide wire 11 thus deployed, the physician cansafely continue advancing the intravenous catheter insertion device 20until the distal tip of the intravenous catheter 13 is in the lumen ofthe vein. Once the intravenous catheter 13 is inserted far enough intothe vein, the physician rotates the handle 9 that rotates the slider 4,which in turn rotates the needle carrier 6 and disengages theinterlocking member 18 of the needle carrier 6 from the matinginterlocking member 19 on the front plug 2. (In the exemplary embodimentdescribed above, the handle moves in a counterclockwise direction asallowed by the triangular cutout 15 at the distal end of the slot 14 inthe outer housing 1. Additional structural features of the actuatormechanism are shown in more detail in FIGS. 1-3.) When the handle 9 isreleased, the biasing element (here a compression spring 12) urges theneedle carrier 6 and the slider 4 in the proximal direction, thussimultaneously withdrawing the access needle 8 and the safety guide wire11 into the outer housing 1, leaving only the intravenous catheter 13 inthe lumen of the vein. FIG. 8 shows the access needle 8 and the safetyguide wire 11 withdrawing into the outer housing 1. The shape of thetriangular cutout 15 allows the handle 9 to make a smooth transitioninto the elongated slot 14 as it moves proximally under the influence ofthe biasing element 12. Finally, the intravenous catheter 13 isdisengaged from the luer slip 16 fitting on the distal end of the frontplug 2, as shown in FIG. 9, and a source of intravenous fluid, a syringeor other device is attached to the luer fitting 27 of the intravenouscatheter 13.

While it is desirable for the intravenous catheter insertion device 20to withdraw the access needle 8 and the safety guide wire 11simultaneously, the actuator mechanism could also be modified towithdraw the access needle 8 and the safety guide wire 11 sequentially.For example, the actuator mechanism could withdraw the access needle 8first and then, after a slight delay, withdraw the safety guide wire 11.

Alternatively, the actuator mechanism could be modified to require twoseparate motions of one actuator member or selective movements of twoseparate actuator members to withdraw the access needle 8 and the safetyguide wire 11 selectively.

In an alternative embodiment of the intravenous catheter insertiondevice 20, the compression spring 12 may be omitted from the actuatormechanism, thus allowing the access needle 8 and the safety guide wire11 to be withdrawn manually using the handle 9. Once the intravenouscatheter 13 has been inserted into the patient's vein, the handle 9 isrotated laterally to disengage the needle carrier 6 from the front plug2, then the handle 9 is moved proximally along the slot 14 to withdrawthe access needle 8 and the safety guide wire 11 into the outer housing1.

The components of another embodiment of a catheter insertion device 20are illustrated in FIGS. 10A and 10B. FIG. 10A illustrates a housing 1having an interior space 34. The housing 1 is illustrated as a generallycylindrical container with sufficient strength to hold the variouscomponents of the catheter insertion device 20. Attachment feature 40 isalso visible within interior space 34. As is illustrated in the figuresthat follow, attachment feature 40 may be used to secure the restrainingelement 36 to the handle 1 or within the interior space 34. An accessneedle 8 is positioned on and exits the interior space 34 at the distalend of housing 1. The access needle has a distal end 45 and a lumen 46.The access needle 8 is slideable with respect to the interior space 34.A release bar 32 is used to hold the needle 8 within the housing 1. Inthis illustrative embodiment, the biasing member 12 is compressedbetween the housing 1 and the needle support 29. A release button 30 isused to tilt the release bar 32 allowing the biasing member 12 to expandand move the access needle 8 proximally within the interior space.

The catheter insertion devices described herein include a biasingelement adapted and configured that, when released, move the insertionneedle from a position where at least a portion of the needle is outsideof the housing 1 to a position within the interior space 34.Additionally, the same or a different biasing element is adapted andconfigured, when released, to move the guide wire 11 from a positionoutside of the housing to a position within the housing 1. In theconfigurations illustrated in many of the embodiments described hereindistal movement of the needle 8 or guide wire 11 denotes insertion intoa target vessel and proximal movement denotes withdrawal from a targetvessel. Biasing elements are described using this convention forpurposes of discussion. Other movements may be used for advancement intoor withdrawal from and the descriptions of biasing element movement andconfiguration would be adjusted accordingly. In one aspect, a biasingelement is adapted and configured that, when released from a constrainedcondition, moves the needle 8 so that the needle 8 is completely withinthe interior space 34. In another embodiment, a biasing element isadapted and configured to, when released from a constrainedconfiguration, move the guide wire 11 so that the entire length of theguide wire 11 is completely within the interior space 34. In theembodiment illustrated in FIG. 11A, the biasing member 12 is a spring.

FIG. 10B illustrates the guide wire 11 and associated components. In theillustrated embodiment, the proximal end of the guide wire 11 isattached to a guide wire support 38. The distal end of the guide wirewill, in use, extend along the access needle and beyond the distal endof the housing 1. Prior to use, one end of the guide wire 11 is alwaysattached to the handle 1 or within the interior space 34 or both. Afteruse, the guide wire 11 is completely within the handle 1 or within theinterior space 34. The handle 9 is directly or indirectly attached tothe guide wire. The handle 9 is moveable relative to the housing 1 tomove the guide wire 11 relative to the interior space 34.

The guide wire support 38 and the guide wire 11 may be joined using anysuitable technique. The guide wire support 38 is used to providemechanical strength to the guide wire 11 since the guide wire 11 is asmall diameter, flexible line, coil, filament or wire as describedherein and well known in the medical arts. The guide wire support 38 mayhave a shape different that the illustrated embodiment and still meetthe functional requirement of supporting one end of the guide wire 11. Ahandle 9 is attached, directly or indirectly to the guide wire 11 sothat movement of the handle 9 produces movement of the guide wire 11relative to the interior space 34 or the housing 1. In the illustratedembodiment, the handle 9 is attached to the guide wire 11 using theguide wire support 38. FIG. 10B also illustrates a restraining element36. The restraining element 36 is used to prevent movement of the guidewire 11. In one aspect, the restraining element 36 attached to thehandle 9 to limit the motion of the guide wire 11 relative to the accessneedle 8. In the illustrated embodiment, one end of the restrainingelement 36 is attached to the guide wire support 38. The other end orsome other portion of the restraining element 36 is attached to thehandle 1. In one embodiment, the restraining element extends between theguide wire support 38 or the handle 9 and the handle 1 or the interiorspace 34. The restraining element 36 may be attached to an attachmentfeature 40 or by any suitable means to the handle 1 or within interiorspace 34.

FIGS. 10C and 10D illustrate side views of catheter hub embodiments.FIG. 10D is a conventional catheter hub assembly 13. FIG. 10C is acatheter hub 13A with an angled base 61 to allow easier catheter entryinto a vessel as will be further described below with regard to FIGS.19A and 19B.

FIGS. 10E and 10F illustrate various apertures 43 in the access needle 8to provide early indication of vessel puncture. FIG. 10E illustrates asingle indicator opening 43 while FIG. 11F illustrates an embodimentwith two indicators 43. The indicators 43 could have any suitable sizeand shape to provide indication that blood is present in the needlelumen 46. The illustrated shapes are rectangular in FIG. 10E and oval inFIG. 10F. Circular shapes could also be used.

FIG. 10G illustrates a top down view of a needle 6, guide wire 11 andthe distal end of the handle 1 attached to a catheter hub 13. The lengthof needle 8 is selected to extend beyond the distal end of the catheteras shown. The needle distal end 45 extends far enough beyond the end ofthe catheter to allow for vessel puncture. The guide wire 11 issupported by and moveable relative to the access needle 8. The guidewire 11 is shown extended from the needle distal end 45.

The guide wire 11 coils into the plane of the page in this illustratedembodiment. The guide wire coil may be formed in the needle lumen 46 andadvanced from the needle 8 in a coiled configuration or the guide wire11 may be constrained into a straight configuration within the accessneedle lumen 46. Once extended out of the access needle lumen 46, theguide wire 11 assumes a previously defined coiled structure. In otherembodiments, the guide wire 11 does not coil but instead remainsstraight during use. Various coil types are shown and described in FIGS.1, 4A, 4B, 5B, 5A, 16A-17B, 22, 23 and 24.

The access needle 8 includes a bleed back indicator 42 visible in thedistal end of a catheter 13 when the access needle 8 is positionedwithin a catheter 13. The bleed back indicator 43 in the illustratedembodiment includes an opening 43 in the sidewall of the distal end ofthe needle 8. The bleed back port 42 is visible through the catheterassembly 13 to provide a nearly immediate indication of vessel puncture.The bleed back indicator 42 is within a portion of the access needle 8that extends beyond the housing 1. As illustrated, the bleed backindicator 42 is an opening 43 that is formed in the needle 8 in aportion of the needle that is distal to the distal end of the housing 1.

FIG. 10G also illustrates the relationship between the guide wire andthe bleed back opening. One consideration in operating guide wireassisted access devices is inadvertent motion of the handle 9. If thehandle 9 is advanced proximally, for example, the guide wire tip may popout of the needle lumen 46 though the flash back channel 43. In thisinstance, the guide wire 11 would need to be re-threaded into the accessneedle lumen 46. FIGS. 11A and 11B illustrate one technique to preventthis undesired proximal movement using the restraining element 36. Therestraining element 36 is used to restrict the movement of the guidewire 11. As best seen in FIG. 11A, the restraining element 36 isattached to the handle 9 and limits the proximal motion of the guidewire 11 relative to the access needle 8. The restraining element 36 ispulled tight and restricts further proximal movement of the handle 9. Asshown, in the most proximal position prior to activation of the releasebutton 30, the guide wire 11 remains within the access needle 8. In oneembodiment, the restraining element 36 is a strip of Kevlar fabric cutto fit within the interior space 36. The restraining element 36 may beany of a wide variety of materials that will limit or prohibit themovement of the guide wire. The restraining element 36 could also be aflexible element that provides increasing resistance as the handle ismoved to provide the user with a tactile feedback that the furthermovement of the handle in that direction is undesired.

Similar to FIGS. 7-9 above, FIGS. 11A-14B will be used to describe aillustrative catheter insertion sequence. The insertion of the catheter13 and the operation of an embodiment of a catheter insertion device 20will be described using a sequence of figures having a section view ofthe interior of the housing 1 and an illustration of the device beingused to access a vessel.

FIG. 11A illustrates the housing 1 in position ready to use the needleto puncture a vessel. Note that the proximal movement of handle 9 islimited by the restraining device 36 so that the guide wire 11 remainsin position within the interior space 34 and the needle lumen 46. FIG.11B illustrates the device 20 inserted within a catheter 13 prior tovessel stick. FIG. 11C illustrates the needle 8 piercing through thevessel walls (vw) and into the vessel. Blood (B) appears in the bleedback indicator 42. Bleed back indicator 42 provides an early indicationof vessel puncture. The guide wire 11 is maintained within the accessneedle lumen 46 between distal end of needle 45 and the bleed backopening 43.

FIG. 12A illustrates the interior component position after guide wireadvance. As shown, handle 9 has been moved distally relative to thehousing 1. This movement advanced the guide wire 11 beyond the needledistal end 45 and reduced the tension in restraining element 36. FIG.12B illustrates the guide wire 11 assuming a coiled shape after exitingthe needle 8. Continued movement of the handle 9 advanced the guide wire11 further into the vessel (v).

FIG. 13A illustrates the catheter 13 advanced beyond the needle distalend 45 and along the guide wire 11. Once the catheter is inserted intothe vessel v, the guide wire 11 and access needle 8 can be withdrawn.Withdrawal of the guide wire 11 and needle 8 can occur in a wide varietyof ways. Withdrawal may be simultaneous or sequential. If sequential,either the guide wire or the needle may be withdrawn first. Withdrawalmay be performed by manual operation of a knob, handle, slider or othercomponent attached directly or indirectly to either the guide wire 11,the needle 8 or to both the guide wire 11 and the needle 8. Withdrawalmay also be performed using an automatic mechanism configured towithdraw on or both of the guide wire 11 and the needle 8. Automaticwithdrawal of one element may be combined with manual withdrawal of theother element. Irrespective of withdrawal technique or sequenceperformed, a complete withdrawal sequence ends with both the needle andthe guide wire proximal to the distal end of the housing 1 and/or withinthe interior space 34. In one aspect, at the conclusion of thewithdrawal operation both the guide wire 11 and the needle 8 arecompletely within the interior space 38 so that sharp and blood exposedcomponents are stowed within the housing 1. (see e.g., FIGS. 14A, 1513C, 18G, and 31).

An automatic withdrawal sequence will be described beginning with FIG.12A. The release button 30 is depressed so that the release bar 32 islifted clear of the proximal end of needle support 29. The biasingmember 12 is now unconstrained in the proximal direction and will expandthat way. As the biasing member 12 moves proximally it will also movethe needle support 29 proximally and along with it the needle 8.Proximal movement of the needle support 29 will also move the guide wiresupport 38 and handle 9 proximally along with the guide wire 11. FIG.13B illustrates the proximal movement of the guide wire 11 shown nearthe distal end of the catheter 13 instead of further down the vessel asshown in FIG. 13A. FIG. 13C illustrates continued proximal movementindicated by the arrow. Here both the guide wire 11 and the needle 8have been withdrawn from the catheter 13 and are now proximal to thedistal end of housing 1. FIG. 13D is a section view of the housing 1 atthe conclusion of the withdrawal sequence. At the conclusion of thewithdrawal operation, the catheter 13 is inserted into the vessel v butthe housing 1 is still attached to the catheter 13 as shown. The needle8 and guide wire 11 are both proximal to the distal end of the housing 1and within the interior space 34. Additionally, FIG. 13D illustratesboth the guide wire 11 and the needle 8 completely within the housing 1and interior space 34.

FIG. 14A illustrates the housing 1 disconnected from the catheterassembly 13. At this point, the housing 1 is ready for disposal and thecatheter 13 is within the vessel as shown in FIG. 14B. As shown in FIGS.14A and 15, the needle distal end 45 is withdrawn a distance d from thehousing distal end 35. The needle 8 and the guide wire 11 are completelywithin the housing interior 34. The distance d may be adjusted based ona number of design factors such as the housing length, needle length,size of and energy stored in the biasing element, and the length oftravel needed for withdrawal. The distance d may be from 1 mm to about20 mm or may be just proximal to the housing distal end 35 asillustrated in FIG. 18G.

Returning to FIG. 14A, once the needle 8 and guide wire 11 are withdrawninto the housing 11, the blood exposed and sharp components of thedevice 20 typically the needle 8 and the guide wire 11, are within thehandle interior space 34. This additional feature to provide additionalsecurity to ensure that the needle and the guide wire remain in thehousing or within the interior space. In one aspect of the invention, arestraining element is positioned within the interior space 34 to limitdistal movement of one or both of the access needle 8 or guide wire 11.The restraining device is positioned within the interior space based onthe length of travel needed during a withdrawal sequence. Therestraining element is, in some embodiments, positioned within theinterior space 36 near the end of travel for the needle and/or guidewire. The end of travel for the needle and guide wire may vary withapplication. When positioned properly, the distal movement of the guidewire 11, the needle 8 or any component connected to the guide wire orthe needle will be restricted so that neither the guide wire nor theneedle will extend from the distal end of the housing 1. Alternatively,when positioned properly, the distal movement of the guide wire 11, theneedle 8 or any component connected to the guide wire or the needle willbe restricted so that the guide wire and the needle will remain withinthe interior space 34. The interior space 34 could be a cavity withinthe housing 1 or it could the hollow space within housing 1.

In one embodiment, the restraining device restricts both proximal anddistal movement. In another embodiment, the restraining device allowsproximal movement but restricts distal movement. FIG. 15 illustrates oneembodiment of a restraining device 64 within the interior space 34. Therestraining device 64 has a truncated cone shape with the base openedtowards the distal end of the housing 1. The restraining device is madeof a flexible material with sufficient access to allow the one wayproximal movement of the guide wire 11, needle 8 and the associatedsub-components. In the illustrated embodiment, the restraining device isadapted and configured to seize on the proximal end of the needlesupport 29. The restraining device 29 could be configured to engagewith, capture, confine or restrict any component in order to maintainthe desired position of the guide wire and the needle. The restrainingdevice 64 could also be a narrowing within the interior space 34 thatproduces a friction fit between the interior walls of the housing andthe guide wire and/or needle components. In addition, the guide wire andneedle components could be configured to engage and lock upon initiationof proximal movement of either the needle or the guide wire. In oneembodiment, proximal movement locks the guide wire and the needletogether such that they move as a single unit proximally within thehousing 1. The restraining device 64 is then adapted and configured toengage with a feature on one of the guide wire or the needle or on thesingle guide wire/needle unit.

In another embodiment, the restraining device 64 includes one or morepins angled towards the proximal end of the interior space 34. Virtuallyany shape that will allow one way (here, proximal) passage of theneedle/guide wire and prevent the opposite movement (here, distally)could be used. While illustrated as confining the movement of the needleguide, this is only for purposes of discussion. The retraining devicecould be adapted and configured to engage within any component of theneedle or guide wire assemblies so long as the engagement allowswithdrawal into the housing interior and prevents advancement out of thehousing interior. Other restraining features and configurations include,for example, one or more rings, wedges, or any other friction lockconfiguration.

The guide wire 11 may have any of a number of different configurationsincluding curved, coiled and straight configurations as shown anddescribed in FIGS. 3, 4A, 4B, 5A-5C, 8, 22, 23 and 24 or in any otherconfiguration conventional to field of guide wires for medicalapplications. In the illustrative embodiments of FIGS. 16A-17B, theguide wire 11 is coiled within the access needle lumen 46. FIGS. 16A-17Billustrate end views (FIGS. 16A and 17A) and isometric views (FIGS. 16Band 17B) of the distal portion of an embodiment of an access needle 8used in a catheter insertion device 20. The illustrated access needles 8a and 8 b have a distal end 45 and an interior wall defining a lumen 46that extends from the distal end to a proximal end. As described abovewith access needle 8, the access needles 8 a and 8 b are slideablerelative to the interior space 46 and extend beyond the distal end ofthe housing 1. An opening 43 in the sidewall of the access needles 8 a,8 b is in communication with the access needle lumen 46. The opening 43in the sidewall of the access needle is positioned proximal to theaccess needle distal end 45. A guide wire 11 is supported by the accessneedle.

The lumen of the access needles 8 a, 8 b have a cross section shape thatmaintains the orientation of the guide wire 11 relative to the accessneedle lumen 46. The access needles 8 a, 8 b illustrate access needlelumens having a non-circular cross section shapes. In one aspect, theshape of the access needle lumen is used to maintain the orientation ofthe guide wire to help prevent the guide wire from inadvertently exitingthe access needle lumen through the bleed back indicator or opening 43.In the illustrative configurations of the FIGS. 16A-17B, if the guidewire 11 is withdrawn proximally into the area of the bleed back opening43 then either a feature (FIGS. 16A and 16B) or the interior shape inthe needle (FIGS. 17A and 17B) maintains the guide wire 11 in anorientation that will prevent the guide wire 11 from exiting the accessneedle lumen 46 via the opening 43. The orientation maintaining featuresillustrated in FIGS. 16A-17B may be used alone or in combination witheach other. In another variation, an orientation maintaining feature maybe used in combination with or in lieu of the restraining device 36described and illustrated in FIGS. 10B and 11A.

In some embodiments, a feature formed within the access needle sidewallmaintains the orientation of the guide wire 11 relative to the accessneedle lumen 46. The feature could be any formed on or in the sidewallor a separate component joined to the sidewall. FIGS. 16A and 16Billustrate a feature 52 formed within the access needle sidewall tomaintain the orientation of the guide wire 11 relative to the accessneedle lumen. In the illustrated embodiment feature 52 is a grooveformed along the sidewall. The depth of the groove is sufficient toconfine the guide wire 11 and maintain its orientation within the needlelumen 46.

In the embodiment illustrated in FIGS. 17A and 17B, the cross sectionshape of the access needle lumen 46 is used to confine the guide wire 11in the needle lumen 46 to prevent the guide wire 11 from exiting thelumen 46 through the bleed back opening 43. FIGS. 17A, 17B illustrate anaccess needle lumen 46 having an elliptical cross section shape. Othercross section shapes may be used to confine the guide wire 11 within theaccess needle lumen 46.

In one embodiment, the access needle lumen 46 confines the coiled guidewire 11 to form at least one half of a rotation within the access needlelumen 46. In an alternative embodiment, the access needle lumen confinesthe coiled guide wire 11 to form one or more rotations within the accessneedle lumen 46.

Another challenge related to the use of guide wire aided vessel accessdevices is the premature distal advancement of the guide wire during orprior to needle puncture. FIGS. 18A-18H illustrate an embodiment of acatheter insertion device 20 having a main channel 14 and a guidechannel 70. The main channel 14 within the housing 1 confines themovement of the handle 9 along the housing 1. The guide channel 70 isadjacent to and accessible from the main channel 14. The guide channel70 is adapted to prevent or restrict movement of the handle 9 once thehandle 9 is in the guide channel 70.

The insertion device illustrated is used in an insertion sequencesimilar to the sequence described and illustrated above in FIGS. 7-9,and FIGS. 11A-14B. The components and operation of the catheter device20 in FIGS. 18A-18H are similar to the embodiments described above andthe same reference numbers are used on similar elements. The guidechannel is an example of an additional feature to restrict or preventdistal movement of the guide wire 11. The housing 1 has a guide channel70 in addition to the main channel 14. The guide channel 70 is best seenin the isometric view of FIG. 18B.

FIGS. 18A and 18B illustrate side and isometric views respectively of anembodiment of a catheter insertion device 20 with handle 9 in a proximalposition in the main channel 14. This embodiment of the catheterinsertion device 20 includes a housing 1 having an interior space 34. Anaccess needle 8 is slideable with respect to the interior space 34 andextends from the distal end of the housing 1. A guide wire 11 issupported by and moveable relative to the access needle 8. A handle 9 isattached to the guide wire. The movement of the handle is limited sothat at least a portion of the guide wire 11 always remains in theinterior space 34. In the illustrated embodiment, the handle 9 isattached to the guide wire 11 using the guide wire support 38. Thehandle 9 and the guide wire support 38 could be a single component. Asillustrated in the beginning of the sequence (FIG. 18A) and the end ofthe sequence (FIG. 18G) the movement of the handle 9 is confined so thatthe guide wire proximal portion 11A always remains in the interior space34.

As shown in FIG. 18A, proximal movement of the handle 9 is restricted orstopped by the restraining device 36. As best seen in FIG. 18B, eventhough the handle 9 and the guide wire 11 are with drawn proximally, theguide wire 11 remains within the needle lumen 46 distal to opening 43and proximal to distal end 45. In the embodiment illustrated in FIGS.18A-18D the restraining element 36 prevents proximal guide wire movementand the holding channel 70, when used, prevents distal guide wiremovement. One end of the guide wire 11 is secured to the housing 1 usingattachment point 40. As shown in FIGS. 18A and 18B the guide wire 11 isdisposed within the access needle 8.

Guide channel 70 may also include a friction or interference fit orotherwise restrict the handle 9 once the handle 9 is moved into theguide channel. For example, the guide channel may have a uniform widthwith a lock, tab or other feature in the distal end of the channel 70 toreleasably secure the handle 9 within the channel 70. Alternatively,movement of the handle relative to the guide channel 70 may be used tolock and unlock the handle 9 from the guide channel 70. For example, thehandle 9 may move into a J-shaped guide channel to lock and out of thej-shaped channel to return to the channel 14. In another alternativeembodiment, the width of the guide channel 70 decreases distally tocause a friction with a distally advanced handle 9.

FIGS. 18C and 18D illustrate the handle 9 advanced distally into theguide channel 70. As compared to FIGS. 18A, 18B, the distal movement ofthe handle 9 produced corresponding distal movement of the guide wire11. As best seen in FIG. 18D, the guide wire 11 is still within theaccess needle 8 and proximal to the distal end 45, the guide channel 70is so designed that when the handle 9 is moved into the channel 70, theguide wire 11 remains within the needle 8. For those embodiments wherethe needle 8 includes an opening 43, the channel 70 confines the guidewire 11 movement between the opening 43 and the distal end of the needle45.

FIGS. 18E and 18F illustrate guide wire advancement as described andillustrate above in FIGS. 8, 12A, and 13. FIGS. 18E and 18F alsoillustrate a catheter insertion device embodiment where one end of theguide wire 11 is constrained within the interior space 34 when the guidewire 11 is extended beyond the access needle distal end 45.

FIGS. 18G and 18H illustrate the position of the components at theconclusion of a withdrawal sequence as described and illustrated abovewith reference to FIGS. 9, 13A, 13B, 13C, 13D, 14 and 15. FIG. 18Gillustrates the withdrawal of the needle distal end 45 to a positionjust proximal to the housing distal end 35. This final position is incontrast to FIGS. 14A and 15 where the needle distal end 45 is withdrawna distance d from the housing distal end 35. The spatial relationship ofthe components used in this configuration may be altered so that theneedle distal end may be withdrawn a distance d. In each of theembodiments described herein, the guide wire is withdrawn to the sameposition or proximal to the needle distal end 45, or at least proximalto the housing distal end 35 or a distance d as described.

FIGS. 18A-18D illustrate the restrictions on handle 9 movement providedby restraint device 36 and the guide channel 70. The catheter insertiondevice 20 may also be provided to a user in a “ready for use”configuration illustrated in FIGS. 18C and 18D. In this configuration,inadvertent distal guide wire 11 advancement is mitigated by theplacement of the handle 9 in the guide channel 70. In order to advancethe guide wire 11 distally or beyond the needle distal end 45, thehandle 9 and guide wire 11 are moved proximally as needed to free thehandle 9 from the guide channel 70. This proximal movement is limited bythe restraining device 36 as shown in FIG. 18A to maintain the guidewire 11 in the needle 8. Thereafter, the handle 9 and guide wire 11 isadvanced distally as described herein for catheter insertion followed bya needle/guide wire withdrawal sequence.

Another challenge facing vessel puncture or entry generally is providingan orientation of the catheter for patient comfort after insertion. Onepotential orientation issue is best illustrated in FIG. 14B. FIG. 14Billustrates a conventional catheter hub assembly 13 where the catheterlumen is bent down to accommodate the flat base and generallyrectangular arrangement of the hub. In contrast, FIGS. 19A and 19Billustrate an angled catheter lumen. The catheter lumen angle θ isselected to optimize the approach angle of the needle 8 for entering thevessel v. As shown in FIG. 19A, the housing 1 is aligned with thecatheter lumen. As a result, the needle 8 is also aligned to thecatheter lumen angle θ. FIG. 19 is a section view of the catheter hub13A illustrating catheter lumen angle θ formed between the base 61 andthe catheter lumen. In one embodiment, the catheter lumen angle θ rangesfrom about 0 degrees to about 90 degrees. In another embodiment, thecatheter lumen angle θ ranges from about 0 degrees to less than about 25degrees. The catheter 13A is used differently that the catheter hub 13.As shown in FIGS. 7 and 11C the housing and catheter unsupported abovethe vessel where the catheter base is not in contact with the skin. Incontrast, when catheter 13A is used, base 61 is in contact the with skinand, when properly placed on the skin, the catheter lumen angle θ may beused to guide the needle distal end 45 through the skin and into thevessel v. An angled catheter hub may increase patient comfort and reducethe possibility of catheters being inadvertently pulled out. Theseadvantages result from the hub and lumen will be in better contact withthe skin because catheter lumen is angled for insertion into the vessel.

FIG. 20 illustrates an embodiment of a catheter insertion device havinga housing 1 with an interior space 34 and a longitudinal axis. Thefeature 80 is positioned on or formed from the housing distal end 35.When the feature 80 is coupled to a catheter 13, the housinglongitudinal axis is offset from the longitudinal axis of the catheter13. The offset is indicated by the housing offset angle β. Asillustrated, the housing offset angle β is about 10 degrees to about 15degrees. In other embodiments, the housing offset angle β ranges fromabout 5 degrees to less than about 50 degrees. The access needle 8passes through the feature 80 and is and attached to a needle carrier orother component within the housing 1. The needle and/or needle carrieris slideable with respect to the interior space 34 and the access needle8 is slideable relative to the feature 80. In one embodiment, when thefeature 80 is coupled to the catheter 13 the housing longitudinal axisis offset from the longitudinal axis of the catheter to form a housingoffset angle β of less than 180 degrees. In another aspect, when thefeature 80 is coupled to the catheter 13 the housing longitudinal axisis offset from the longitudinal axis of the catheter to form a housingoffset angle β of less than 60 degrees. In another aspect, when thefeature 80 is coupled to the catheter 13 the housing longitudinal axisis offset from the longitudinal axis of the catheter to form a housingoffset angle β of less than 45 degrees. As a result of the offset angleβ, the withdrawal sequence will produce needle and guide wire movementthat it initially at an angle to the longitudinal axis of the housingand corresponding to the offset angle β. After passing through thefeature 80, the withdrawal movement would change into a movement that isparallel and in some embodiments coextensive with the longitudinal axisof the housing 1. As such, once the guide wire and/or needle arewithdrawn past the feature 80, the access needle and the guide wire arewithdrawn into the interior space 34 substantially parallel to thelongitudinal axis of the housing 1.

Another technique to adjust the angle of entry into the vessel and easethe use of the catheter insertion device involves altering the pointwhere the needle exits the housing. It is believed that by moving theneedle exit from the central portion of the housing as illustrated inthe previous embodiments and conventional to safety syringes generally,a different access angle is formed between the housing 1 and the targetvessel.

FIG. 21 illustrates an embodiment of a catheter insertion device havinga housing 1 with an interior space 34 and a longitudinal axis. Theinterior space 34 is sized and configured to contain all of the guidewire 11 and the access needle 8 after catheter insertion is complete. Anaccess needle 8 is slideable with respect to the interior space 34. Theneedle axis is offset from the housing longitudinal axis. The offsetneedle is closer to one wall of the housing and exits the housing from anon-central portion of the housing distal end. Here, the needle axisextends parallel and below the housing longitudinal axis.

The biasing element 12 is coextensive with the housing axis. The releasebar 32 is adapted to engage the needle support 21 where positionedtowards one wall of the housing. Otherwise, the components operate asdescribed above to needle and guide wire insertion and withdrawal.

In the illustrated embodiment, the longitudinal axis of the housingextends through the axis of the biasing element 12. The guide wire 11 iscoextensive with the needle 8. The needle axis is parallel to but offsetfrom the housing longitudinal axis. The biasing element 12 is above theneedle 8 in contrast to previous embodiments where the needle and thebiasing element were coextensive. Here the needle and guide wire may bemoved closed to one wall of the housing. As a result, the needle exitsthe housing closer to one wall thereby allowing the housing to be heldcloser to the skin than in previous embodiments where the needle exitedthe housing in about the middle of the housing. In another aspect, therestraining element 36 and attachment point 40 may be moved above theneedle to aid in moving the needle closer to one wall of the housing.

Various guide wire configurations are available as illustrated anddescribed in, for example, FIGS. 1, 3, 4A, 4B, 5A, 5B, 5C, 8, 10B, 10G,and 16A-17B. Additional guide wire designs may also be used with thecatheter insertion devices described herein. As illustrated anddescribed herein, the guide wire 11 could be used in a coiled, uncoiledor curved configuration. In addition, the distal end of the secondportion comprises one or more of a full radius distal tip, a sphericalball of the same material as the guide wire, a spherical ball of adifferent material than the guide wire or a distal end having a diameterabout the same as the first diameter.

FIG. 22 is a section view of a guide wire 11 having a first portion witha first diameter, a reducing section 84 and a second portion with asecond diameter that is less than the first diameter. The guide wiredistal end 85 is formed into a rounded tip 87 or a ball tip 87 isattached to distal end 85. The first diameter and the second diameterare less than the interior diameter of the access needle 8. In oneembodiment, the first diameter is formed from 0.008 inch diameter wireand the second diameter is formed from 0.004 inch diameter wire having afull radius distal end 85. The transition or taper 84 is a linear changefrom the first diameter to the second diameter as illustrated. In oneembodiment, the tip 87 is a spherical ball having a diameter between0.005 and 0.012 inches formed with or a separate component attached todistal end 85. The spherical ball 87 may be formed from any metal,alloy, plastic, nitinol or other material suited for use in the body.

FIG. 23 is a section view of a guide wire 11 having a first portion witha first diameter, a reducing section 84 and a second portion with asecond diameter that is less than the first diameter. The guide wiredistal end 85 is formed into a rounded end. The first diameter and thesecond diameter are less than the interior diameter of the access needle8. In one embodiment, the first diameter is formed from 0.008 inchdiameter wire and the second diameter is formed from 0.004 inch diameterwire having a full radius distal end 85. The transition or taper 84 is alinear change from the first diameter to the second diameter asillustrated. In an alternative embodiment, the transition segment 84 isremoved and the guide wire has a single diameter from proximal to distalend. In one specific embodiment, the wire used for the guide wire has adiameter of 0.006 inches.

FIG. 24 illustrates a guide wire 11 formed in a braided structure 89.

In one exemplary embodiment, the braided structure 89 is formed fromnitinol wore having a 0.002 inch diameter.

FIGS. 25A and 25B illustrate one embodiment of a guide wire 11 having acoiled portion 91. FIG. 25A is a side view of the guide wire 11 having afirst diameter region, a taper or transition region 84 and a seconddiameter region formed into a coiled portion 91. The coil portion 91 maybe described in terms of coil width (cw) and coil span (sc). Coil width(cw) is best seen in FIG. 25A. Coil span (cs) is best seen in FIG. 25B.In one embodiment, the distal tip 85 moves through an angulardisplacement of at least 180 degrees when moving from a straightconfiguration (FIG. 23) to a coiled configuration (FIG. 25A). In anotherembodiment, the distal tip 85 moves through an angular displacement ofno more than 270 degrees when moving from a straight configuration (FIG.23) to a coiled configuration (FIG. 25A). In another embodiment, thecoiled portion 91 includes at least one completely formed coil. Inanother embodiment, the coil width is from about 0.04 to about 0.05inches. In another embodiment, the coil span is less than 0.015 inches.

FIGS. 26A and 26B illustrate section views of a catheter insertiondevice embodiment similar in many aspects to the device illustrated anddescribed above in FIGS. 10A, 10B and 11A. FIG. 6 utilizes a springloaded drum 24 to provide a mechanism to ensure complete withdrawal ofthe guide wire 11 into the housing 1 when the length of guide wire 11used exceeds the length of the housing. Along the same lines as FIG. 6,FIGS. 26A and 26B illustrate a catheter insertion device that alsoprovides a mechanism to withdraw a length of guide wire 11 longer thanthe length of the housing 1.

FIGS. 26A and 26B illustrate an embodiment of a catheter insertiondevice with a pulley 98 secured within the interior space 34. The pulley98 is configured to facilitate movement of the guide wire 11 into theinterior space 34. FIG. 26A illustrates another catheter insertiondevice embodiment where one end of guide wire is constrained in theinterior space when the guide wire is advanced beyond the needle distalend 45.

The housing interior 34 is dimensioned to store more guide wire but in amanner that accounts for the fact that the guide wire to be retrieved islonger than the housing 1 and at the conclusion of the withdrawaloperation sequence, all of the guide wire 11 is within the housing 1.The guide wire 11 passes around the pulley 98 and is attached to thehousing at attachment 40 a. The biasing member 12 a replaces the biasingelement 12. The biasing member 12 a is extended as the guide wire 11 isadvanced distally as shown in FIG. 26A. When released, the pulley 98moves proximally within the housing 1 as shown in FIG. 26B. The proximalmovement of the pulley is the motive force for a withdrawal sequenceused to withdraw the needle 8 and guide wire 11 as described above. Thereference numbers used correspond to components described above thatperform similar functions in this embodiment.

FIGS. 27A-27E illustrate several section views of the distal end of anaccess needle 8 configured for use with a guide wire channel 54. Inthese embodiments, the guide wire channel 54 is supported by the accessneedle 8. In one embodiment, the guide wire channel 54 is suitablydimensioned needle that is attached to the access needle 8 using anysuitable joining or bonding technique. The guide wire channel diameteris less than half the size of the access needle diameter in someembodiments. In other embodiments the guide wire channel diameter rangesfrom 0.016 inches to about 0.028 inches. In other embodiments, theaccess needle is a standard size, commercially available needle and theguide wire channel is also a standard size, commercially availablelarger gauge needle. For example, if the access needle is a standard 17gauge needle (0.058″ diameter) then the guide wire channel may be anylarger gauge needle such as 18 gauge to 27 gauge. In other embodiments,the guide wire channel is a standard, gauge needle selected toaccommodate the guide wire 11. For example, a 27-20 gauge needle(diameters ranging from 0.016-0.035 inches) may be used for a guide wirediameter of 0.008 inches depending upon desired amount of clearance. Inother configurations the guide wire channel inner diameter is abouttwice the diameter of the guide wire in the channel 54.

In the embodiments that follow, the side of the needle having distal end45 will denote the bottom of the needle and the side opposite thatsurface as the top of the needle. FIG. 27A illustrates an embodimentwhere the guide wire channel 54 is on top of the needle 8. The guidewire 11 remains in the guide wire channel 54. In this embodiment, theguide wire may be advanced proximally and distally without passingthrough or within the access needle lumen 46.

FIG. 27B illustrates an embodiment where the guide wire channel 54 is onthe bottom of the needle 8. The guide wire 11 remains in the guide wirechannel 54. In this embodiment, the guide wire may be advancedproximally and distally without passing through or within the accessneedle lumen 46. FIG. 27B1 illustrates an alternative embodiment wherethe guide channel 54 is a needle with a distal tip 57 positionedadjacent the access needle distal tip 45.

FIG. 27C illustrates an embodiment where the guide wire channel 54 is onthe top of the needle 8 inside the needle lumen 45. In this embodiment,the length of guide wire channel 54 is less than the length of theaccess needle lumen. The access needle includes a port 58 in the needlesidewall distal to the end of the guide wire channel and proximal to thedistal end of the needle. The guide wire passes out the end of the guidewire channel through the port 58 and into the vessel. The guide wire 11remains in the guide wire channel 54 for most of the length of theaccess needle lumen.

FIG. 27D illustrates an embodiment where the guide wire channel 54 is onthe top of the needle 8. In this embodiment, the length of guide wirechannel 54 is less than the length of the access needle lumen. Theaccess needle includes a port 58 in the needle sidewall at the end ofthe guide wire channel and proximal to the distal end of the needle. Theguide wire passes out the end of the guide wire channel through the port58 and into the access needle lumen 46. The guide wire 11 remains in theguide wire channel 54 for most of the length of the access needle lumen.

FIG. 27E illustrates an embodiment where the guide wire channel 54 is onthe top of the needle 8 inside the needle lumen 45. In contrast to FIG.27C, the access needle does not include a port 58 in the needlesidewall. As with FIG. 27C, the length of guide wire channel 54 is lessthan the length of the access needle lumen. However, instead of exitingthe needle lumen, the distal to the end of the guide wire channel opensinto the needle lumen proximal to the distal end of the access needle.The guide wire passes out the end of the guide wire channel passesthrough the distal end of the needle lumen and hence into the vessel v.As with the previous embodiments, the guide wire 11 remains in the guidewire channel 54 for most of the length of the access needle lumen butdoes not exit the guide channel and enter the vessel directly as withthe embodiments of FIGS. 27A, 27B and 27B1.

While described as using a single button to automatically withdraw boththe guide wire and the needle with a single action, one of the guidewire or the needle may be with drawn from the vessel manually. Inanother alternative, both the guide wire and the needle are withdrawnmanually. In one aspect of this embodiment, the biasing element 12illustrated in FIG. 10A may be removed and the needle support 29attached to a second handle. In this embodiment, needle withdrawal isaccomplished by moving the second slider attached to the needleproximally until the needle is within the housing interior 34. Inaddition, the device may be adapted so that the handle 9 may be used tomanually withdrawn the guide wire separately or in sequence with theneedle withdrawal.

The above described catheter insertion devices may be used to perform anumber of different methods of introducing a catheter into a vessel. Oneexemplary basic method includes three steps. First, insert a guide wiresubstantially contained within a housing into a vessel. Next, advance acatheter over the guide wire and into the vessel. Finally, withdrawingthe guide wire out of the vessel and completely into the housing.

The basic method may include other steps. In one alternative, the guidewire is advanced along and within a needle inserted into the vesselbefore performing the inserting step. In another alternative, the guidewire is advanced along and outside a needle inserted into the vesselbefore performing the inserting step. In yet another alternative, theguide wire is advanced within a guide wire channel before entering thevessel. In yet another aspect, the guide wire is coiled within thevessel after the inserting step, while in the access needle or afterexiting a guide wire channel.

Other alternative or modified method steps may also be performed. In oneaspect, the withdrawing step is accomplished manually and in anotherembodiment withdrawal occurs automatically. In one alternative, thewithdrawing step is accomplished by releasing a biasing member towithdraw the guide wire completely into the housing. In another aspect,releasing a biasing member also withdraws a needle supporting the guidewire completely into the housing. In one alternative, the withdrawingstep or a withdrawal sequence is initiated by pushing a button. In anadditional aspect, a step of inserting a needle attached to the housinginto the vessel is performed before the step of inserting a guide wirestep. One additional optional step includes using a flashback indicatornear the distal tip of the needle to determine that the needle hasentered the vessel after the inserting a needle step. In another aspect,the method may include the step of moving a handle attached to the guidewire proximally before the inserting step.

Each of the patent application, patents and references mentioned in thisapplication are incorporated herein by reference in it's entirely.Additionally, each of U.S. Pat. No. 4,747,831; U.S. Pat. No. 4,509,945;U.S. Pat. No. 4,900,307; and U.S. Pat. No. 5,749,371 are incorporatedherein by reference in its entirety.

While the present invention has been described herein with respect tothe exemplary embodiments and the best mode for practicing theinvention, it will be apparent to one of ordinary skill in the art thatmany modifications, improvements and sub-combinations of the variousembodiments, adaptations and variations can be made to the inventionwithout departing from the spirit and scope thereof. For example, alldimensions and materials included in the specification or drawings areintended only as examples of presently preferred embodiments and are notintended to limit the scope of the invention.

1. (canceled)
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 4. The catheter insertiondevice according to claim 47 wherein the access needle comprises a bleedback indicator visible in the distal end of a catheter when the accessneedle is positioned within a catheter.
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 13. The catheter insertion device according to claim 47wherein the guide wire has a first portion with a first diameter, areducing section and a second portion with a second diameter that isless than the first diameter.
 14. (canceled)
 15. The catheter insertiondevice according to claim 13 wherein the distal end of the secondportion comprises one or more of a full radius distal tip, a sphericalball of the same material as the guide wire, a spherical ball of adifferent material than the guide wire or a distal end having a diameterabout the same as the first diameter.
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 30. The catheter insertiondevice according to claim 47 wherein the access needle constrains theguide wire into a non-coiled configuration within the access needle. 31.(canceled)
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 47. A catheter insertion device,comprising: a housing having an interior space; an access needle that isslideable with respect to the interior space; a guide wire supported byand moveable relative to the access needle; and a handle attached to theguide wire wherein the movement of the handle is limited so that atleast a portion of the guide wire always remains in the interior space.48. The catheter insertion device according to claim 47 furthercomprising: a biasing element adapted and configured to move the needlecarrier proximally within the interior space when released.
 49. Thecatheter insertion device according to claim 48 wherein the biasingelement is adapted and configured to move the guide wire proximallywithin the interior space when released.
 50. The catheter insertiondevice according to claim 48 wherein the biasing element is adapted andconfigured that, when released, moves the needle so that the needle iscompletely within the interior space.
 51. The catheter insertion deviceaccording to claim 49 wherein the biasing element is adapted andconfigured to move the guide wire so that the entire length of the guidewire is completely within the interior space.
 52. The catheter insertiondevice according to claim 47 further comprising: a restraining elementwithin the interior space that limits distal movement of the accessneedle or guide wire within the interior space once the access needle orguide wire has moved proximal to the restraining device.
 53. (canceled)54. The catheter insertion device according to claim 47 wherein one endof the guide wire is constrained within the interior space when theguide wire is extended beyond the distal end of the access needle. 55.The catheter insertion device according to claim 47 wherein the guidewire is disposed within the access needle.
 56. (canceled)
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 79. The catheter insertiondevice according to claim 47 further comprising: a restraining elementwithin the interior space that limits distal movement of the accessneedle or guide wire within the interior space either after the accessneedle or guide wire have been withdrawn into the interior space afteruse to insert a catheter or such that the access needle and guide wireremain completely withdrawn into the interior space.
 80. The catheterinsertion device according to claim 47 further comprising: an opening inthe sidewall of the access needle in communication with the accessneedle lumen; and a restraining element attached to the guide wire andconfigured to prevent the guide wire from moving into the opening orwhen the guide wire is positioned within the access needle distal to theopening, the restraining element limits proximal movement of the guidewire towards the opening.
 81. The catheter insertion device of claim 47further comprising: a feature on the distal end of the housing that whencoupled to a catheter offsets the housing longitudinal axis from thelongitudinal axis of the catheter to form an angle if less than 180degrees.